The impact of coronary chronic total occlusion percutaneous coronary intervention on culprit vessel physiology

Completed

Conditions: Chronic Total Occlusions (CTO)
10011082

Registration Number: NL-OMON48075

Lead Sponsor: Basildon and Thurrock University Hospitals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

* > 18 years of age
* Willing to participate and able to understand, read and sign the informed
consent document before the planned procedure.
* Presence of a coronary CTO scheduled for elective PCI
* Evidence of viability in the CTO territory
* Presence of additional coronary lesions (other than the CTO vessel) in need
of FFR/PCI in a second session.

Exclusion Criteria

* < 18 year of age
* Unable to give informed consent
* Known severe chronic kidney disease (creatinine clearance *30 mL/min),
unless the patient is on dialysis
* Unable to receive antiplatelets or periprocedural anticoagulation
* Any study lesion characteristic resulting in the expected inability to
deliver FD-OCT catheter at the distal vessel post CTO PCI (e.g. moderate or
severe vessel calcification or tortuosity)
* Pregnancy or planning pregnancy during study period

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints<br /><br>- To identify changes in absolute coronary flow, fractional flow reserve,<br /><br>pressure and microvascular resistance (physiological measures) between index<br /><br>and three months follow-up after successful PCI of chronic total coronary<br /><br>occlusion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br>- To a identify changes in vessel diameter (anatomical measures) between index<br /><br>and three months after successful PCI of chronic total coronary occlusion.<br /><br>- To identify a relation between anatomical changes and physiological<br /><br>measurements between index and three months.<br /><br>- To identify a relation between intra plaque and sub-intimal recanalization<br /><br>techniques and changes in anatomical/physiological measures between index and<br /><br>three months follow-up after successful PCI of chronic total coronary occlusion.<br /><br>- To identify a relation between anatomical/physiological measurements and<br /><br>quality of life</p><br>